A Cross-Sectional Post-Authorization Safety Study to Assess Healthcare Provider Awareness of Risks Associated with Zydelig® in the European Union

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  To Assess Healthcare Provider Awareness of Risks Associated with Zydelig® in the European Union
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Survey of medical oncologists and hematologists in the European Union

Population studied

• Short description of the study population:
  Practicing oncologists and hematologists in the United Kingdom, Italy, Spain, France and Germany who treat patients with Chronic lymphocytic leukemia (CLL) or Follicular lymphoma (FL) representing specialties considered likely to prescribe Zydelig.; Patients with following criteria were included:; 1. Registered oncologists and hematologists; 2. Registered medical doctors who are currently enrolled in an advanced training program leading to specialization in oncology and/or hematology
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  To determine the HCPs’ level of knowledge about the newly identified infection risks associated with Zydelig treatment and the corresponding recommendations to minimize these risks.
• Data analysis plan:
  Responses to questions for all completed surveys were analyzed using descriptive statistics. Continuous variables were described by the mean, standard deviation, median and range. Categorical variables were described by the number and proportion in each category. The amount of missing data for each variable were reported. Data were presented by summary tables and/or graphs. No formal hypothesis testing was conducted. An 80% threshold for prescriber awareness was generally considered acceptable.The numbers of invitees and respondents were recorded, and the response rates were reported overall and by country.

Documents

Study results

CSR-Final-PASS-GS-EU-313-4226